Incyte's and Syndax's Graft Disease Treatment Niktimvo Gets FDA Approval for Vial Sizes

Dow Jones

Jan 16, 2025

By Sabela Ojea

Incyte and Syndax Pharmaceutical said the Food and Drug Administration approved their graft disease treatment Niktimvo antibody in nine milligram and 22 milligram vial sizes.

The biopharmaceutical companies on Wednesday said that they expect the product to be available for order in the U.S. early in February. Incyte has exclusive commercialization rights for Niktimvo outside the U.S.

Niktimvo was approved by the FDA on Aug. 14 for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms. Graft-versus-host disease is a severe complication that can occur following hematopoietic stem cell transplantation.

Write to Sabela Ojea at sabela.ojea@wsj.com

(END) Dow Jones Newswires

January 15, 2025 18:12 ET (23:12 GMT)

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Incyte has exclusive commercialization rights for Niktimvo outside the U.S. \n</p>\n<p>\n  Niktimvo was approved by the FDA on Aug. 14 for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms. 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","BK4585":"ETF&股票定投概念","BK4139":"生物科技","BK4532":"文艺复兴科技持仓"},"translate_title":"Incyte和Syndax的移植物疾病治疗药物Niktimvo获得FDA批准的小瓶尺寸","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SNDX":0.9,"INCY":1},"content_text":"By Sabela Ojea \n\n\n \n\n\n  Incyte and Syndax Pharmaceutical said the Food and Drug Administration approved their graft disease treatment Niktimvo antibody in nine milligram and 22 milligram vial sizes. \n\n\n  The biopharmaceutical companies on Wednesday said that they expect the product to be available for order in the U.S. early in February.  Incyte has exclusive commercialization rights for Niktimvo outside the U.S. \n\n\n  Niktimvo was approved by the FDA on Aug. 14 for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms. Graft-versus-host disease is a severe complication that can occur following hematopoietic stem cell transplantation. \n\n\n \n\n\n  Write to Sabela Ojea at sabela.ojea@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  January 15, 2025 18:12 ET (23:12 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}